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FDA 510(k)

Stellar M22

K-Number: K250809 · 2025-04-16

ApplicantLumenis Be, Ltd.
Decision Date2025-04-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Stellar M22 is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis Be, Ltd.. It received FDA 510(k) clearance on 2025-04-16 under 510(k) number K250809. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stellar M22?

Stellar M22 is a medical device that received FDA 510(k) clearance on 2025-04-16. The listed applicant is Lumenis Be, Ltd.. The 510(k) number is K250809.

When did Stellar M22 receive FDA 510(k) clearance?

Stellar M22 received FDA 510(k) clearance on 2025-04-16, under 510(k) number K250809.

Who is the listed applicant for Stellar M22?

The FDA 510(k) record lists Lumenis Be, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stellar M22?

The FDA product code for Stellar M22 is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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